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news.Canadian pharmaceutical firm Antibe Therapeutics has suspended the development of its lead drug, ATB-346, due to safety concerns encountered in its Phase I clinical trial.
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ATB-346 targets the need for a safer non-steroidal anti-inflammatory drug (NSAID) for chronic pain and inflammation.
According to the company, safety concerns centered on the finding of significant liver enzyme elevations in one subject in the highest dose cohort, and additional liver enzyme elevations were seen in other subjects in the higher dose cohorts.
The company is concerned that, when evaluated together, these liver enzyme elevations are indicative of potential hepatotoxicity.
Antibe CEO Dan Legault said: "Our primary concern is with the health of the subjects.
"We are very disappointed by these unexpected findings and will fully assess our options moving forward."
No indication of potential hepatotoxicity has been provided according to the pre-clinical studies on ATB-346.
Currently, the company continues to collect and evaluate data to report back to the scientific community and the market with further details on its data review and corporate strategy as appropriate.
The company’s technology involves linking a hydrogen sulfide-releasing molecule to an existing drug to produce a patented, improved medicine.